Non-invasive, bedside intra-cranial pressure and brain shift/herniation monitoring unit utilizing early on-set auditory evoked responses

ABSTRACT

Systems and methods are taught for non-invasively monitoring brainstem function and intra-cranial pressure in a patient. Repeated auditory stimulation is applied to the patient in at least one ear to generate an auditory brainstem response. The response waveform is detected with an electrode at a location on the patient&#39;s head. The detected waveform data is compared with known waveform data and an alarm is initiated when a change in the auditory brainstem response is detected based on the comparison that is indicative of a corresponding change in intra-cranial pressure in the patient.

RELATED APPLICATIONS

This application is a continuation of U.S. application Ser. No.12/032,384, filed Feb. 15, 2008, which is a non-provisional filing ofU.S. Provisional Application No. 60/890,116, filed Feb. 15, 2007.

BACKGROUND

This invention relates to monitoring intracranial pressure, and inparticular to non-invasive intracranial monitoring using waveformsevoked from a patient.

The invention provides a system capable of monitoring intra-cranialpressure (ICP), using early onset auditory brainstem response (ABR),modified auditory brainstem response (MABR) and electrocochleography(ECochG) methods. The invention is used to estimate when ICP isincreased, or has increased compared to the patient's earlier baselinevalue. This nurse-friendly, monitoring and warning system constitutes animportant bedside surveillance system for a high risk patient group. Itis fully automated in both the presentation of auditory stimuli andimmediate analysis of the recorded potentials—not requiring that aneurologist, neurosurgeon or neurophysiologist be present for the testor its interpretation.

Increased ICP is commonly seen in conditions such as brain tumors, headinjury, stroke, or cerebral fluid (CSF) build up in hydrocephalus. Themanagement of increased intra-cranial pressure remains a major obstacleto the successful treatment of many patients with life-threateningintra-cranial spacetaking lesions. At the present time, the measurementof ICP requires an invasive procedure—a hole must be drilled through theskull and often the cerebrum must be punctured. Various medical orsurgical measures may be used to alleviate increased ICP if detected ina timely fashion. Patients with headaches or certain findings onclinical examination such as drowsiness or focal neurological signs orbrain scans that suggest increased ICP, are usually seen in an emergencyroom and closely observed in the intensive care unit (ICU)Unfortunately, even today, patients with brain masses may rapidlydeteriorate as lesions enlarge, and the urgency of surgical or medicalmeasures to combat increased ICP can be misjudged. Nurses and physiciansmay be short staffed or busy with other patients, and neurologicalstatus may be clouded by sedative medications given for headache orrestlessness.

It has been known for many years that increased ICP is frequentlyassociated with fullness in the ears, mild or moderate usually low tonehearing impairment, and dizziness or imbalance. The cause is likelyrelated to the cochlear aqueduct, a distinct channel in the basal skullthat interfaces CSF with perilymph destined for the cochlea. Animalstudies bear out direct increased CSFIICP pressure transmission to theinner ear and associated damping of electrocochleography (EcochG)potentials. EcochG has not previously been used in patients withincreased ICP. Some comparison has been made to Meniere's disease or‘endolymphatic hydrops-typified by episodic symptoms of vertigo,progressive sensorineural hearing loss tinnitus, and fullness in theear—with disturbed EcochG potentials recorded from symptomatic patients.

Early-onset or short latency auditory evoked responses (ECochG, ABR,MABR) are robust, reliably recorded potentials largely refractory to thepresence of depressant and anesthetic medications or the patient's levelof consciousness—making these responses an ideal choice in the intensivecare setting. Wave V—the most prominent waveform of the ABR and MABR,and the chosen target for automated analysis, is generated from thecritical midbrain region of the brainstem. This same region is highlyvulnerable to the effects of transtentorial brain herniation, the mostcommon and fatal form of deterioration in patients with intracranialmass lesions and increased ICP. Thus the ABR and MABR Wave V can capturethe early phases of this devastating deterioration associated withincreasing ICP.

Many studies have demonstrated abnormalities in the conventional orstandard click-evoked auditory brainstem response (ABR) in patients withincreased ICP, and reversal of these abnormalities with normalization ofICP. The standard ABR is well known to be sensitive to brain stemlesions or compression, as found in later stages of increased ICP.However, the invention mirrors rises in ICP compared to a patient'searlier baseline, and captures mild or moderate increases in ICP, andalso the late stages of actual brain stem shift.

Published reviews in this field have yielded the knowledge that theconventional or routine-click evoked ABR, without actual midbrain shift,may reflect moderately increased ICP in less than one-half of patients,but often with only nonspecific abnormalities. This led the presentinventor to develop the MABR to further challenge the cochlea yet keepthe test practical and require minimal time. However, the results ofthese studies could not be accessed in a timely manner, as required tobe useful to a critically ill patient under observation, andnecessitated a neurologically trained physician or clinicalneurophysiologist to interpret the results. Ordinarily, evoked potentialstudies require such a professional for interpretation.

SUMMARY

The invention is a user-friendly automated system that samples andautomatically analyzes early auditory responses, and produces a timelywarning signal to alert nursing staff or others of changes reflectingincreased ICP. In one form of the invention, it is directed to anintracranial pressure monitoring system, comprising an auditorystimulation and recording unit, which includes a stimulation controller,a memory for storing at least one of established patient baselinewaveform data and normative range waveform data, a device for generatinga comparison by comparing received waveform data with establishedpatient baseline waveform data or normative range waveform data, and analarm which is operable based upon that comparison.

At least one cranial electrode is provided, which is attachable to apatient. An audible stimulation device is included, operable by thestimulation controls.

In accordance with the preferred form of the invention, the auditorystimulation device includes at least one ear stimulation instrument andan auditory stimulator connected to the ear stimulation instrument.Preferably, there is a pair of ear stimulation instruments, and each earstimulation instrument comprises an acoustic ear insert.

Preferably there is a plurality of the cranial electrodes, for judiciousplacement cranially on a patient. Between three and five electrodes maybe used.

The alarm may be audible, visual or a combination of audible and visual.

The method according to the invention comprises the steps ofauditorially stimulating a patient to evoke a received waveform dataindicative of intracranial pressure, then generating a comparison bycomparing the received waveform data with one of established patientbaseline waveform data and established normative waveform range data,and, finally, generating an alarm responsive to that comparison.

BRIEF DESCRIPTION OF THE DRAWINGS

The invention is described in greater detail in the followingdescription of examples embodying the best mode of the invention, takenin conjunction with the drawing figures, in which:

FIG. 1 is a block diagram of a system according to the invention.

FIG. 2 is an example of use of the invention with ABR click or puretone, and

FIG. 3 illustrates use of the invention with MABR.

DETAILED DESCRIPTION

Patients would greatly benefit if a safe, non-invasive bedside methodexisted to automatically sample and interpret physiologic signals thatreflect increasing ICP in a timely manner. The system of the inventionis used to monitor ICP utilizes MABR or/and EcochG methodology, and isnot significantly affected by patients taking depressant or paralyticmedications, or under general anesthesia. The system should greatlyimpact patient care, save lives, and lead to fewer invasive ICPmonitoring procedures. The system should be a valuable back-up safetymeasure to existing medical and surgical management, including invasiveICP monitors which can fail about 7% of the time.

As explained in greater detail below, the invention may utilizeconventional components, such as Bio-logic (Natus/Bio-logic, Mundelein,IL) instrumentation and accessories. A commercially available NavigatorPro laptop based unit can be used to perform stimulation, recording,amplification, averaging, and display of waveforms. A separate componentstimulator and preamplifier is attached directly to the patient.Auditory stimulation is delivered by soft foam ER 3A insert headphonesplaced just within the external ear canal, and all recordings bynoninvasive skin surface stick-on or gel electrodes. A Biologic TM(tympanic membrane) electrode is exclusively used for ECochG.Natus/Bio-logic is additionally a leader in the manufacture anddistribution of automated, nurse friendly ABR devices used routinelyworld-wide as a hearing screen in neonates.

Electrocochleography (ECochG)—Analysis of electrical signals generatedby the cochlea which—require proximity to the inner car to be reliablyrecorded following moderately loud (100-105 dBpeSPL) auditory clickstimulation delivered by insert headphones. An adequate eighth nerveaction potential (AP) voltage of about 1 microvolt (uV) is recorded fromthe tympanic membrane (TM) electrode referred to the contralateralmastoid skin surface (nasion ground) with a latency of about 1.5millisecond after the auditory stimulation. In addition to the AP, aretwo earlier cochlear hair-cell receptor potentials whose onset beginswith the auditory stimulation—the cochlear microphonic (CM), andsummating potential (SP).

Auditory Brainstem Response (ABR)—consists of five positive vertex scalprecorded waves generated by the auditory nerve and 4 auditory brainstemnucleii or tracts, recorded within 6 to 7 milliseconds. Foam insertheadphones deliver a moderately loud (100-105 dBpeSPL) auditory clickstimulus at approximate rates between 11-22 per second. Wave V (andfollowing Vn) are usually most prominent with a voltage (amplitude)approaching ½ microvolt (uV). For ABR the active skin surface electrodeis placed at the frontal vertex (Fz) and referenced at the ipsilateralmastoid skin surface. A surface ground electrode is placed at thenasion. The ABR, most notably Wave V, can also be generated by an insertheadphone that delivers a pure tone burst stimulus, and is recorded withidentically placed recording electrodes. In some instances, this tonalABR may have more promise than the conventional click ABR in capturingICP.

Modified Auditory Brainstem Response (MABR) - is elicited by a rapidclick stimulation rate of about 40-70 per second and binaural (bilateralsimultaneous) presentation to both ears, both modifications augment theamplitude of the prominent Wave V (and Vn) which are the major waveformsof interest The frontal vertex (Fz) referred to C2 neck linkage alsoaugments Wave V amplitude. A ground is placed at the nasion. Thisaugmentation is necessary since the MABR is performed at 4 moderateloudness intensities (i.e. 85,75,72,65 dBpeSPL), all well below that ofthe standard ABR (100-105 dBpeSPL). These maneuvers stress the cochlea,yet yield a robust Wave V (approximately 1 uV) for automated Wave Vrecognition, Wave V latency/intensity and Wave V amplitude/intensitycurves for analysis, display if desired, and warning. An MABR wave V(and Vn) can also be generated by a pure tone.

This invention is for a bed-side auditory stimulation and surface scalprecording device that can use tympanic membrane recordedelectrocochleography (ECochG), the conventional click-evoked, or puretone burst auditory brainstem response (ABR), and modified click or toneburst evoked ABR (MABR) tests involving bilateral (binaural) orunilateral- rapid stimulation rates of diminishing stimulationintensities to create Wave V latency/intensity and Wave Vamplitude/intensity decay curves. Easily tolerated soft foam insertheadphones deliver the stimuli and simple skin surface electrodes areused for recording the potentials. Wave V, the most prominent ABRwaveform, can be windowed and captured (peak picking) with softwarefacilitating automated wave form recognition and analysis. Software canalso handle waveforms derived at diminishing intensities and create theabove mentioned latency/intensity and amplitude/intensity curves. Whenthese curves reach critical values compared to an earlier baseline inthe same patient or curves derived from normals, a warning tone andlight alerts hospital staff of the concern for increasing ICP in thepatient. The early-onset evoked response battery can be automaticallyset to be administered every 10 or 20 minutes (etc), as determined bythe nursing staff or physicians.

A non-invasive, bedside intra-cranial pressure monitoring system 10according to the invention is generally illustrated in block form inFIG. 1. The system 10 includes an auditory stimulation and recordingunit 12 which may, as explained below, be a single unit or a series ofindividual elements joined as a unit. The auditory stimulation andrecording unit 12 is used for monitoring the ICP of a patient 14, asalso explained further below.

The auditory stimulation and recording unit 12 includes a CPU 16, whichmay be a general purpose computer, as identified above, and whichincludes all software and memory needed in order to perform not onlystorage of waveform data, but also analysis required by the invention.The CPU 16 thus includes, as indicated on the CPU 16, memory, the masterprogram necessary for operation, automated peak recognition foranalyzing waveform data received from the patient 14, latency/intensitycurves which provide normative range waveform data, and baseline andpopulation comparisons. The baseline can include patient baselinewaveform data collected from the patient 14, and the populationcomparisons can include waveform data gathered from patients with knownlevels of increased ICP. A user input 18, which may be as simple as akeyboard, is used to import data into the CPU 16.

The unit 12 also includes alarm and parameters display 20. The display20 can be as simple as an audible alarm, or a visual display, or acombination of both audible and visual displays to provide an indicationrelative to comparison of waveform data received from the patient 14with data stored in the CPU 16.

The unit 12 also includes a stimulator control 22. The stimulatorcontrol 22 is used to send stimulating signals to the patient 14 via acable 24, or wirelessly if wireless connections are used.

For appropriate connection to electrodes placed on the patient 14, theauditory stimulation and recording unit 12 is connected through atypical preamplifier 26. Depending on the system being used to obtainwaveform data from the patient 14, electrodes 28 through 36, which maybe non-invasive skin surface stick on or gel electrodes, are employed.The electrodes 28 through 36 are connected via cables 38 to thepreamplifier 26 and then to the auditory stimulation and recording unit12.

For auditory stimulation, ear inserts 40 and 42 are used. The inserts 40and 42 may be standard soft foam insert headphones which are placed justwithin the external ear canal of the patient 14. Each of the ear inserts40 and 42 is activated by a respective conventional auditory stimulator44 and 46 through a respective acoustic tube 48 and 50.

FIG. 2 illustrates the invention, using auditory brainstem response(ABR). For this purpose, the electrode 30 is placed at the frontalvertex and the electrode 32 is placed at the nasion as a surface groundelectrode. The electrodes 34 and 36 are mastoid electrodes from whichwaveform data may also be obtained.

FIG. 3 illustrates the use of the invention with MABR. The electrode 30is connected to the frontal vertex and the electrode 32 is connected atthe nasion as a ground. The electrode 28 is connected at the neck toaugment the wave V amplitude.

Initiation of an alarm at the display 20 depends on set limits that areset in the unit 12. Intensive care unit monitoring of early-onset (shortlatency) auditory evoked responses is similar to intra-operativemonitoring, and if there is a fifty percent drop in the wave Vamplitude, or ten percent increase in wave V latency, compared to thepatient's baseline waveform data, the CPU 16 can be set to issue awarning via the display 20. Other limits can also be set, such as a waveV latency shift or wave V amplitude drop beyond 2.5 standard deviationscan trigger a warning by the display 20.

While the invention has been described with respect to comparison ofpatient waveform data with either the patient's baseline waveform dataor normative range waveform data, it can also be compared with otherwaveform data, such as waveform data from a group of patients with knownlevels of increased ICP.

Even more rapid rates of auditory stimulation (100 or more clicks ortone bursts per second—requiring maximum-length sequence techniques) maybring out first and higher order nonlinear responses, which may provemore sensitive to changes in ICP. A stimulator and preamplifiercomponent may be attached directly to the patient, held by a neck bandor pocket, and this portable component (the size of a deck of cards)communicating wirelessly with the near-by bedside unit 12. The patientcould return from tests without a need to remove the electrodes or earinserts, and once again be within range of the base unit for monitoring.

Various changes can be made to the invention without departing from thespirit thereof or scope of the following claims.

What is claimed is:
 1. A method of non-invasively monitoring brainstemfunction, comprising the steps of repeatedly auditorially stimulating apatient at a first location over a period of time to evokebrainstem-generated electrical waveform data, detecting thebrainstem-generated electrical waveform data electronically at alocation separate from said first location, comparing the detectedbrainstem-generated electrical waveform data with at least one selectedfrom a group consisting of established patient baseline waveform data,established normative range and abnormal range waveform data, andearlier waveform data obtained from the patient, and detecting a changein the brainstem function of the patient over the period of time basedon the comparison.
 2. The method according to claim 1, in whichrepeatedly auditorially stimulating a patient at a first locationincludes repeatedly auditorially stimulating the patient in a first earusing one acoustic ear insert.
 3. The method according to claim 2,further comprising repeatedly auditorially stimulating the patient in asecond ear using a second acoustic ear insert.
 4. The method accordingto claim 1, in which detecting the brainstem-generated electricalwaveform data electronically includes detecting the brainstem generatedelectrical waveform data electronically using at least one selected froma group consisting of a cranial electrode and a neck electrode.
 5. Themethod according to claim 1, in which repeatedly auditoriallystimulating the patient includes applying a pure tone burst stimulus. 6.The method according to claim 5, in which detecting thebrainstem-generated waveform data includes detecting waveform datacomprising at least one selected from a group consisting of Wave V andWave V_(n).
 7. The method according to claim 5, in which applying thepure tone stimulus includes applying the pure tone burst stimulus at arate of from about 40 per second to about 70 per second.
 8. The methodaccording to claim 1, in which detecting the brainstem-generatedwaveform data includes detecting an auditory brainstem responsewaveform, and in which repeatedly auditorially stimulating the patientincludes auditorially stimulating using a click stimulus.
 9. The methodaccording to claim 8, in which auditorially stimulating using the clickstimulus is includes applying the click stimulus at a rate of from about11 per second to about 22 per second.
 10. The method according to claim8, in which detecting the brainstem-generated waveform data includesdetecting brainstem-generated electrical waveform data comprising atleast one selected from a group consisting of Wave V and Wave V.
 11. Themethod according to claim 1, in which detecting the brainstem-generatedwaveform data includes detecting brainstem-generated electrical waveformdata comprising a modified auditory brainstem response waveform, and inwhich repeatedly auditorially stimulating the patient includesauditorially stimulating using a rapid click stimulus.
 12. The methodaccording to claim 11, in which auditorially stimulating using the rapidclick stimulus includes applying the click stimulus at a rate of fromabout 40 per second to about 70 per second.
 13. The method according toclaim 11, in which detecting the brainstem-generated waveform dataincludes detecting brainstem-generated electrical waveform datacomprising at least one selected from a group consisting of Wave V andWave V_(n).
 14. The method according to claim 11, in which repeatedlyauditorially stimulating the patient includes applying in at least oneear, at a plurality of moderate and diminishing loudness intensities, atleast one selected from a group consisting of a pure tone burst stimulusand a click stimulus.
 15. A method of non-invasively monitoring cranialpressure in a patient, comprising the steps of repeatedly auditoriallystimulating a patient in at least one ear to generate an auditorybrainstem response waveform; detecting the auditory brainstem responsewaveform with an electrode at a location on a head of the patient;comparing the detected waveform with known waveform data; and initiatingan alarm when a change in the auditory brainstem response waveform isdetected based on the comparison, wherein the detected change in theauditory brainstem response waveform is indicative of a correspondingchange in cranial pressure.
 16. The method according to claim 15, inwhich repeatedly auditorially stimulating a patient includes repeatedlyauditorially simulating the patient in a first ear using at least oneacoustic ear insert.
 17. The method according to claim 16, furthercomprising repeatedly auditorially stimulating the patient in a secondear using a second acoustic ear insert.
 18. The method according toclaim 15, in which detecting the auditory brainstem-response waveformdata includes detecting an auditory brainstem-response waveformcomprising at least one selected from a group consisting of Wave V andWave V_(n).
 19. The method according to claim 15, in which repeatedlyauditorially stimulating a patient includes applying an auditorystimulus at a plurality of moderate and diminishing loudnessintensities.
 20. The method according to claim 15, in which repeatedlyauditorially stimulating a patient in at least one ear includes applyinga pure tone stimulus.
 21. The method according to claim 15, in whichrepeatedly auditorially stimulating a patient in at least one earincludes applying a rapid click stimulus.
 22. The method according toclaim 15, further comprising: detecting a first auditory brainstemresponse waveform with the electrode at the location on the head of thepatient; and storing data indicative of the first auditory brainstemresponse waveform to a memory, wherein detecting the auditory brainstemresponse waveform includes detecting a second auditory brainstemresponse waveform, the second auditory brainstem response waveform beingdetected subsequent to the first auditory brainstem response waveform,and wherein comparing the detected waveform with known waveform dataincludes comparing the second auditory brainstem response waveform withthe stored data indicative of the first auditory brainstem responsewaveform.
 23. The method according to claim 15, further comprisingdefining a normative range of waveform data, wherein comparing thedetected waveform with the known waveform data includes comparing thedetected waveform data with the defined normative range, and whereininitiating the alarm when the change in the auditory brainstem responsewaveform is detected includes initiating the alarm when waveform data isdetected that is outside of the defined normative range.